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SAP Block for Postoperative Pain (Cardiac-SAP Trial)
N/A
Waitlist Available
Research Sponsored by Nova Scotia Health Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Summary
This trial tests a pain relief method using a local anesthetic injected near the chest muscles for heart surgery patients. It aims to reduce pain by numbing chest nerves, helping patients recover more comfortably.
Who is the study for?
Adults over 18 undergoing heart valve replacement/repair or bypass surgery via sternotomy can join. They must not be allergic to ropivacaine, have a BMI over 35, weigh less than 50 kg, use high-dose opioids, need emergency surgery, or have severe liver/kidney disease.
What is being tested?
The trial is testing if the serratus anterior plane (SAP) block with Ropivacaine reduces pain after heart surgery compared to a saline placebo. Participants are randomly chosen to receive either the drug or placebo for three days post-surgery.
What are the potential side effects?
Possible side effects of the SAP block may include local discomfort at injection site, potential nerve damage, low blood pressure due to numbing medication spread and allergic reactions to Ropivacaine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence rate
Combined major block-related adverse event rate
Recruitment rate
+1 moreSecondary study objectives
Opioid use
Pain scores
Quality of recovery 15 index (QoR-15)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active serratus anterior plane (SAP) block with Ropivacaine 0.2%Active Control1 Intervention
Group II: Placebo serratus anterior plane (SAP) block with normal salinePlacebo Group1 Intervention
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Who is running the clinical trial?
Nova Scotia Health AuthorityLead Sponsor
288 Previous Clinical Trials
94,512 Total Patients Enrolled
Jon BaileyLead Sponsor
1 Previous Clinical Trials
342 Total Patients Enrolled